[Federal Register Volume 65, Number 64 (Monday, April 3, 2000)]
[Notices]
[Pages 17514-17515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Opportunity for Licensing: Adenovirus Mediated Transfer of Genes

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH), Public Health Service 
(PHS), Department of Health and Human Services (DHHS), seeks a 
licensee(s) to develop gene therapy-based therapeutics that would be 
effective in the treatment of a variety of disease states, particularly 
via transfer of specific genes to the lung. The inventors have 
developed adenoviral

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vectors and pharmaceutical compositions comprising (a) a replication 
defective adenovirus comprising a deletion in the E1A, E1B and E3 
regions and further comprising a DNA segment encoding a specific 
protein of interest operatively linked to a promoter and (b) a 
pharmaceutically acceptable carrier for said vector. Examples of 
proteins of interest would include, but not be necessarily limited to, 
CFTR and 1-antitrypsin.
    The NIH seeks licensee(s) who, in accordance with requirements and 
regulations governing the licensing of government-owned inventions (37 
CFR 404), has the most meritorious plan for the development of a 
therapeutic agent(s) to meet the needs of the public and with the best 
terms for the government. NIH intends to grant the selected licensee(s) 
a world-wide royalty-bearing license(s) to practice the inventions 
embodied in U.S. Patent 6,013,638 entitled ``Adenovirus Comprising 
Deletions on the E1A, E1B and E3 Regions for Transfer of Genes to the 
Lung'' U.S. Patent Application S/N 09/364,839 entitled ``Adenovirus-
Mediated Transfer of Genes to the Lung''; U.S. Patent Application S/N 
09/307,141 entitled ``Adenovirus-Mediated Transfer of Genes to the 
Lung'' and U.S. Patent Application S/N 08/442,262 entitled 
``Replication Deficient Recombinant Adenovirus Vector''. The United 
States of America is an assignee for the patent rights in these 
inventions.

ADDRESSES: Licensing information, a copy of the U.S. patent or 
applications referenced to above or a copy of the NIH License 
Application may be obtained by contacting Richard U. Rodriguez, M.B.A., 
at the Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804 
(telephone 301/496-7056 ext 287; fax 301/402-0220; and E-mail 
[email protected]). A signed Confidential Disclosure Agreement is required 
to receive a copy of any patent application.

SUPPLEMENTARY INFORMATION: One of the hurdles to overcome in most forms 
of somatic gene therapy is the specific delivery of a therapeutic gene, 
encoding a therapeutic protein, to the organ manifesting the disease. 
In the case of the lung, a functional gene can be delivered directly to 
the respiratory epithelium by means of tracheal installation. One 
serious disadvantage with this approach is encountered with the use of 
vectors (such as retroviruses) that require proliferation of the target 
cells for expression of the newly transferred gene because only a small 
proportion of alveolar and airway epithelial cells go through the 
proliferative cycle in one day and because a large proportion of these 
cells are terminally differentiated. Use of the claimed recombinant 
adenoviral vector to transfer a gene to the respiratory epithelium in 
vivo circumvents the problem of slow target-cell proliferation. Other 
advantages would include: rare recombination events; no known 
associations of human malignancies with adenoviral infections despite 
common human infection with adenoviruses; the adenovirus genome can be 
manipulated to accommodate foreign genes expressing proteins ranging in 
size from small peptides up to a peptide of 7.0 to 7.5 kB in length; 
and live adenovirus has been safely used as a human vaccine.

    Dated: March 24, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-8107 Filed 3-31-00; 8:45 am]
BILLING CODE 4140-01-P